Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Traumatic stress as measured by Life Events Checklist
研究概览
简要总结
The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •self-identified as a Black woman
- •at least 21 years of age
- •fluency in English
- •International Classification of Diseases (ICD)10 diagnosis of hypertension
- •being a South Florida resident
- •willing to be audio-recorded
排除标准
- •History of psychosis disorders
- •absence of vision and cognitive impairment
- •absence of epilepsy disorders
- •absence of motion sickness.
研究组 & 干预措施
VR-Stress Management Group
Participants in this group will receive VR intervention for up to 6 months
干预措施: VR Stress Management (Other)
Education Control Group
Participants in this group will be exposed to standard care through educational materials for up to 6 months.
干预措施: Education Control (Behavioral)
结局指标
主要结局
Change in Traumatic stress as measured by Life Events Checklist
时间窗: Baseline and up to 12 months
This self-report checklist screens for potentially traumatic events in an individual's lifetime. Scores range from 1 to 17, higher scores indicate higher traumatic exposures. It consists of 17 questions with responses such as "happened to me," "witnessed it," "learned about it," "part of my job," "not sure," and "doesn't apply."
Change in stress as measured by Perceived Stress Scale (PSS)
时间窗: Baseline and up to 12 months
scores ranging from 0 (no symptoms) to 40 (highest severity).
Change in discrimination as measured by Intersectional Discrimination Index (InDI)
时间窗: Baseline and up to 12 months
scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.
Change in stress as measured by the chronic stress scale
时间窗: Baseline and up to 12 months
The Chronic Stress Scale is a 51-item scale that evaluates the perceived experience of chronic stress. Scores range from 0 (not true) to 2 (very true).
Change in stress as measured by the Stress in Context (SIC) Questionnaire
时间窗: Baseline and up to 12 months
The SIC Questionnaire is a 21-item survey assessing stress perception in specific contexts (e.g., home, work, social relationships), with scoring from 1 (never) to 4 (usually).
Change in stress as measured by the Giscombe Superwoman Schema Questionnaire
时间窗: Baseline and up to 12 months
It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales. subscale items are summed to create one Super Woman Schema (SWS) total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS
次要结局
- Change in blood pressure(Baseline and up to 3 months after intervention)
- Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)(Baseline and up to 12 months)
- Change in objective sleep health as measured by Sleep Health Objective(Baseline and up to 12 months)
研究者
Judite Blanc
Assistant Professor
University of Miami